Arm restraint for surgery tables

ABSTRACT

An arm restraint system is provided for restraining movement of an arm of a patient&#39;s body lying over a top surface of a table. A padded restraint is configured to at least partially receive the arm of said patient to thereby maintain the arm at a position laterally adjacent to the patient&#39;s body without the arm being restrained by tucking. In one example, the system includes a rigid support frame located at a lateral edge of said table and the padded restraint is securely fixed to the rigid support frame via a repositionable fastener to inhibit movement of the patient&#39;s arm relative to the rigid support frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims benefit of U.S. patentapplication Ser. No. 14/658,671, filed Mar. 16, 2015, and U.S.Provisional Application No. 61/952,960, filed Mar. 14, 2014, the entiredisclosures of which are hereby incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to patient restraints forsurgery tables, and more particularly, to a patient arm restraint systemfor an operating room table.

BACKGROUND OF THE INVENTION

A number of operating room table accessory devices have been developedin an attempt to safely restrain patients from moving on the surgicaltable while laying in the supine position. The supine position may bemaintained when the table is horizontal, tipped laterally or tipped intoa head up angulation or into a down angulation a position known in theindustry as the Trendelenburg position where the angle of head down tilttypically ranges from 20° to 50° with respect to a ground surface.

It is well-known in the medical industry that, for performing modernsurgical procedures requiring supine the upper extremities are to berestrained at the side of the patient. Traditional wisdom has dictatedthat the arms be restrained by wrapping a linen or a disposable drawsheet around the arm which is then tucked beneath the patient or themattress. Historically, when positioning patients for surgicalprocedures requiring that the patient's arms are held against thepatient's body, the surgical team has used woven or non-woven sheets tobundle the arm against the side of the body. One risk of operating roomacquired patient nerve injury occurs when the arm is bundled and heldagainst the body with excessive compression. Another known risk factoris that surgeon(s) or assistant(s) often inadvertently lean against thepatient's arm when attempting to remain within an ergonomic arms-lengthof the operative site or while attempting to stabilize their posture ifthey become fatigued. Other, more serious, patient risks includeinstances when the patient monitoring lines may become disengaged or anintravenous line may become dislodged, kinked or occluded leading to adisruption in the flow of IV fluids. The resultant emergent situationrequires that the anesthesia caregiver gain immediate access to theaffected site. This normally requires time consuming “un-bundling” ofthe arm. After the refastening or repositioning or clearing theocclusion of the lines an even more difficult and time consumingre-bundling, of the arm is necessary.

Gaining rapid access to the upper extremity is important when thepatient monitoring lines may become disengaged or an intravenous linemay become dislodged, kinked or occluded leading to a disruption in theflow of IV fluids. Dealing with those issues often occurs when thepatient is in the extreme head down tilted posture (Trendelenburgposition). The risks of neuropathy increase when, after the emergencyhas been dealt with, the arm is not re-tucked properly. Problems withre-tucking occurs often when the team has reduced access to the drawsheet when the patient is covered with a surgical drape, in a darkenedroom and postured in 30° to 40° of Trendelenburg (head down tilt). Thecombination of the tilt of the table, gravity and weight of theappendage against a loosened restraint is known to be responsible forarms slipping out of the tucking restraint, and falling freely to theside which is known to create very serious injuries. This reportableevent is considered to be extremely serious and places the patient atrisk for painful and debilitating nerve and muscle injury.

Moreover, it is not uncommon in the performance of Minimally InvasiveSurgery of organs of the pelvis as well for Robotic assisted surgery oforgans of the pelvis that the patient's arms are restrained against thepatient's body when the operating room table is tilted so that thepatient is in an extreme head down tilted position (The TrendelenburgPosition). Added to the normal degree of difficulty in “re-bundling” thepatient arm is the fact that during the surgical procedure the patientis hidden under a sterile protective drape, in a darkened room, posturedin an extreme head down position. While the “un-bundling” allows forrepair or repositioning of the lines the “re-bundling” is difficult toproperly accomplish. This is especially apparent when it must be done ina dark environment with the patient in an extreme head down posturewhile under the sterile protective drape. The “re-bundling” is oftendone so quickly and inadequately that it is commonly known that it isnot an uncommon event that the weight of the arm combined with theeffect of gravity will pull the arm free from the improperly“re-bundled” sheet.

It has been reported in the medical literature that compression relatedto tucking arms can be causal to neuropathy (nerve injuries). TheAssociation of Operating Room Nurses (AORN) is the recognized governingbody for developing the guidelines used by operating room nurses toposition patients. In 2010, AORN issued specific guidelines on patientpositioning recommending against the tucking of arms. Patient risksassociated with tucking include: wrinkles in the draw sheet, armssagging below the top level of the mattress, interference withphysiologic monitoring and the inability to resuscitate during anemergency due to unrecognized IV infiltration in the tucked arm. Thereis also an increased risk for the patient to develop compartmentsyndrome in the upper extremity. Other risk factors for injury includesurgeon(s) or assistant(s) inadvertently leaning directly against thepatient's arm when attempting to remain within an ergonomic arms-lengthof the operative site or while attempting to stabilize their posture ifthey become fatigued.

A number of operating room table accessory devices have been developedin an attempt to restrain patient's arms at their sides during certainsurgical interventions. One common concept includes the utilization ofwhat is known in the industry as a toboggan restraint, which is aprotective plastic containment shell fabricated with an integralhorizontal component that slides under the surface of the operating roompad and is commonly kept in position by gravity and the patient's bodyweight bearing down on the device. The containment shell is lateral tothe patient's arm which is often wrapped in a protective material suchas egg crate foam or a gel material. The toboggan is then used to pushthe arm against the body using un-measurable compressive forces that areknown in the medical literature to have caused nerve injury by placingstrain on joints, nerves and vessels of the upper extremity involved.This is particularly critical if a patient has limited mobility or ifthe joints are affected by degenerative disease or damaged frominjuries. The issue of “tucking and re-tucking” the arm after anemergent circumstance is only slightly less complicated than whentucking the arms with woven or non-woven materials such as linen.

Contemporary ergonomic issues include the common complaint of surgeonsand surgical assistants that leaning against the “toboggan” armrestraint, in an attempt to remain within an ergonomic arms-length ofthe operative site or while attempting to stabilize their posture, isvery uncomfortable. Most recently it has been discovered that whenattempting to use the toboggan during robotic assisted laparoscopicprocedures, the physical height of the toboggan is known to causephysical interference (often referred to as clashing) with the roboticarm which is often in close proximity to the side of the patient's body.This interference is known to restrict the range of motion required bythe robotic arm and keeps it from performing optimally.

Another conventional device that emulates the setup and utility of wovenor nonwoven sheets that are used for tucking arms utilizes foam sheetswith self-adhering hook and loop fasteners that allow the foam fabric towrap around the arm to hold it in place (one example shown in thephotographs labelled as “prior art”). The device functions in much thesame manner as tucking arms and offers little lateral support orprotection for the arm. The absence of lateral support also increasesthe inherent risks that occur when the surgeon(s) or assistant(s) leandirectly against the extremity. The device does not provide horizontalsupport for arms of large patients that extend beyond the outer edge ofthe operating room table mattress. This results in the arm sagging andexacerbates the risk of the arm coming into contact with the hard edgedsurface of the accessory rail of the table. This is known to causeirreparable nerve injury.

This instant invention results from an attempt to provide an innovativedevice that eliminates or minimizes intraprocedural patient injury,meets or exceeds the clinical guidelines in the medical literaturedescribed herein regarding needs for safety, and provides fast and easyanesthesia access and exposure to lines, IV's and ports.

It is to be understood that both the foregoing general description andthe following detailed description present example and explanatoryembodiments of the invention, and are intended to provide an overview orframework for understanding the nature and character of the invention asit is claimed. The accompanying drawings are included to provide afurther understanding of the invention and are incorporated into andconstitute a part of this specification. The drawings, photographs, andattachments illustrate various example embodiments of the invention, andtogether with the description, serve to explain the principles andoperations of the invention.

BRIEF SUMMARY OF THE INVENTION

The following presents a simplified summary of the invention in order toprovide a basic understanding of some example aspects of the invention.This summary is not an extensive overview of the invention. Moreover,this summary is not intended to identify critical elements of theinvention nor delineate the scope of the invention. The sole purpose ofthe summary is to present some concepts of the invention in simplifiedform as a prelude to the more detailed description that is presentedlater.

In accordance with one aspect of the present invention, an arm restraintsystem for restraining movement of an arm of a patient's body lying overa top surface of a table is provided. A rigid support frame is locatedat a lateral edge of said table adjacent to the arm of said patient'sbody and comprises a horizontal surface at least partially disposedunderneath a mattress lying over a top surface of said table, and avertical surface extending upwards from the horizontal surface andcomprising a first repositionable fastener thereon. A padded restraintis configured to at least partially receive the arm of said patient andincludes a deformable material. The padded restraint comprises a centralbody and a pair of tabs on the central body are movable relative to thecentral body. The tabs further comprise a second repositionable fastenerthat is compatible with the first repositionable fastener. The paddedrestraint is securely fixed to the vertical surface of the rigid supportframe, via the second repositionable fastener of the tabs, to inhibitmovement of the patient's arm relative to the rigid support frame andthereby maintain the arm at a position laterally adjacent to thepatient's body without the arm being tucked underneath the patient.

In accordance with another aspect of the present invention, a paddedrestraint is provided for restraining movement of an arm of a patient'sbody lying over a top surface of a table. The padded restraint comprisesa central body, a first pair of projections extending outwards from thecentral body and comprising a first cutout portion therebetween, and asecond pair of projections extending outwards from the central body in adirection opposite the first pair of projections and comprising a secondcutout portion therebetween. A pair of discrete flexible tabs isintegral with the central body that are each connected to the centralbody via a living hinge and independently movable relative to thecentral body via the living hinge. The tabs further comprise arepositionable fastener on an exterior surface thereof. All of thecentral body, first pair of projections, second pair of projections, andpair of tabs comprise a monolithic body made of a deformable material.

It is to be understood that both the foregoing general description andthe following detailed description present example and explanatoryembodiments of the invention, and are intended to provide an overview orframework for understanding the nature and character of the invention asit is claimed. The accompanying drawings are included to provide afurther understanding of the invention and are incorporated into andconstitute a part of this specification. The drawings illustrate variousexample embodiments of the invention, and together with the description,serve to explain the principles and operations of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other aspects of the present invention will becomeapparent to those skilled in the art to which the present inventionrelates upon reading the following description with reference to theaccompanying drawings, in which:

FIG. 1 illustrates a perspective view of an example rigid support frame;

FIG. 2 illustrates a top view of an example padded restraint;

FIG. 3 is a bottom view of the example padded restraint;

FIG. 4 illustrates a top view of the example padded restraint secured tothe rigid support frame;

FIGS. 5-10 illustrate an example method of using the patent armrestraint system of the instant application;

FIG. 11 illustrates a perspective view of a second example rigid supportframe; and

FIG. 12 illustrates an example usage of the second example rigid supportframe.

DESCRIPTION OF EXAMPLE EMBODIMENTS

Example embodiments that incorporate one or more aspects of the presentinvention are described and illustrated in the drawings. Theseillustrated examples are not intended to be a limitation on the presentinvention. For example, one or more aspects of the present invention canbe utilized in other embodiments and even other types of devices.Moreover, certain terminology is used herein for convenience only and isnot to be taken as a limitation on the present invention. Still further,in the drawings, the same reference numerals are employed fordesignating the same elements.

The present application relates generally to patient restraints forsurgery tables, and more particularly, to a patient arm restrain devicefor an operating room table that is used to support, restrain, postureand/or expose the entirety of, or any portion of, one or both of apatient's arms before, during or after the completion of any surgicalprocedure or intervention. The primary role of the device is to providea safe environment for the patient's arm during any surgical procedurerequiring that the arm remain at the side of the patient during thesurgical intervention.

The various objectives of the invention are to provide an improvedrestraint device for positioning patient arms at their sides. Theinvention results from an attempt to provide an innovative device thatis capable of being utilized as: (1) a solution to the nursingguidelines against tucking arms as described herein; (2) to increaseanesthesia care givers immediate access to faulty monitoring cables andnon-functioning IV lines without having to untuck or “re-bundle” theextremity; (3) to provide a safe comfortable surface for surgeon(s) andassistant(s) to lean against while maintaining patient safety fromcompression risk; and (4) to provide an efficient support frame thedesign of which eliminates the potential for intraprocedural clashing ofthe robotic arm. These and other objectives are achieved by combining asupport frame upon which may be attached infinitely adjustable padded orunpadded arm restraints, support or stabilizers according to theinvention.

The arm restraint system 20 includes at least two major elements. Thefirst element, shown in FIG. 1, is a rigid support frame 22 sometimesreferred to as a sled. The rigid support frame 22 comprises asubstantially horizontal surface 24 and a substantially vertical surface26. In one example, the horizontal and vertical surfaces 24, 26 may bearranged substantially perpendicular to each other (i.e., 90 degrees+/−10 degrees), or could be arranged at another relative angle. In oneembodiment, the rigid support frame 22 may be “hard attached” to thesurgical table T accessory rail, such as via depending legs or the like,and in another embodiment, the rigid support frame 22 may be secured bysliding the horizontal surface 24 beneath the table mattress M and heldby friction imparted by the patient's body mass. Physical or visualguides may be provided on the rigid support frame 22 that allow highlyspecific, precise and repeatable placement of primary or secondarypadded arm restraints are located on the support frames. Each rigidsupport frame 22 additionally incorporates an aggressive releasablefastening system 28 across all or a portion of the vertical surface 26that is compatible with that on the padded restraint. Preferably, thefastening system 28 extends across a lower aspect of the verticalsurface 26, although it could extend across a central aspect or upperaspect, or even across a substantial portion or even all of the verticalsurface 26. Lastly, either or both of the horizontal and verticalsurfaces 24, 26 may include structure to enable the rigid support frame22 to be stored in a hanging manner, such as a hole 27, hook, or thelike that can enable hanging storage on a wall, cart, table, cabinet, orthe like.

The second element of the arm restraint system 20 is a specially shaped,infinitely adjustable padded restraint 30, shown in FIGS. 2-3, thatwraps and is fastened around a portion of the patient's arm. The paddedrestraint 30 features integral tabs 32 that utilize aggressivereleasable secured fasteners 34 to secure it to the rigid support frame22. When combined, the rigid support frame 22 and the padded restraint30 provide a safe and secure environment for restraining a patient'sarms at their side to provide upper extremity restraint in lateral,horizontal and vertical planes. As will be clear, it is contemplatedthat one combined rigid support frame 22 and the padded restraint 30 isused to separately restrain each arm (i.e., one for each arm).

The first element, the rigid support frame 22 or sled, is a deviceutilized for the attachment of patient positioning devices capable ofsafely restraining the horizontal and lateral movement of the armspositioned at the sides of patients undergoing surgical interventionswhile laying upon the top surface of any operating room table. In someembodiments multiple frames can be so mounted so as to support a single,particularly large or long arm, or even to simultaneously supportmultiple arms.

The rigid support frame 22 is fabricated from one or more pieces ofrigid materials of such strength and dimension as to be capable ofholding the proportional weight of the upper appendage of a patient witha high body mass index. The sled is preferably made of durable, rigidmaterials that are suitable for use in an operating room and surgicalsetting, such as various metals (e.g., stainless steel, aluminum, etc.)and plastics. Such materials may or may not be radiolucent.

In some embodiments the rigid support frame 22 can restrain or controlthe movement of a patient's arm by being secured to the surgical table Tby gravity and the patient's weight by sliding the horizontal surface 24of said frame 22 transversally under the operating room mattress Mbeneath the patient's torso. The rigid support frame 22 can have anacute bend (i.e., greater than 45° and preferably in the range of about80-110°) that creates a relatively longer surface on the horizontalplane and a relatively shorter surface on the vertical plane.Preferably, the horizontal surface 24 is relatively longer than thevertical surface 26, but they can be the same or the vertical surfacecould even be longer. Sliding the horizontal surface of said rigid frametransversally under the operating room mattress M beneath the patient'storso will utilize friction, gravity and patient weight to secure saidrigid frame during utilization. In such an embodiment, the horizontalsurface 24 of the support frame shall be of such a length as to avoidcoming into contact with the hook and loop fastener that is typicallyutilized to fix the patient mattress M to the operating room table. Therigid support frame 22 may be moved underneath the mattress M in ahorizontal direction toward the foot or the head of the surgical table Tas may be required to locate the arm restraint system 20 in the mostadvantageous position. The rigid support frame 22 may also be fabricatedwith one or more sections of material removed from the horizontalsurface 24 in order to facilitate utilization of said rigid supportframe 22 with operating tables with a perineal cutout or otherprojecting structures that may otherwise interfere with the levelinstallation of the rigid support frame device.

One embodiment of said rigid support frame 22 may be mounted upon thesurgical table T rail utilizing accessory clamps that permit said frameto be fixed to an accessory mounting rail R; such rail R beingconventionally attached along the side of the operating room. In thisconfiguration, the rigid support frame 22 or sled can include one ormore fixed or adjustable width vertical legs 29, blades or posts beingsecurable on the accessory rails on the side of the operating tableusing clamps. It is contemplated that at least one leg can be providedand used to secure the rigid support frame 22 upon the operating roomtable, and optionally two or more legs are used. In one example, asingle leg could be centrally located with respect to the verticalsurface 26, or even offset from the center, and is shaped anddimensioned to be inserted to be inserted into accessory clamps that arecustomarily associated with fixing accessories attached to an accessorymounting rail which is coupled to or integral with to operating roomtables. In another example, a pair of legs 29 could be used on eitherside of the vertical surface that are also shaped and dimensioned to beinserted to be inserted into accessory clamps on an accessory mountingrail of an operating room table. The pair of legs 29 can be secured tothe support frame 22 with a fixed width, or at least one leg can belaterally slidable (preferably two or more legs are slidable) on thesupport frame 22 to be width-adjustable to be more useful with differenttables having different widths and configurations. One example pair oflegs 29 is shown schematically in FIG. 1. It is contemplated that thepair of legs 29 could be coupled to or integral with either of thehorizontal and vertical surfaces 24, 26. In one example, the pair oflegs 29 could be integral with and an extension of the vertical surface26, or alternatively could be part of the horizontal surface 24. Still,in other examples, the any or all of the legs 29 could be removableand/or adjustable relative to the horizontal and vertical surfaces 24,26 (such as where at least one width adjustable leg is desired).

In another embodiment, the rigid support frame 22 can be heightadjustable in order to avoid clashing with robotic arms when the rigidframe is being employed during robotic assisted surgical interventions.For example, the vertical surface 26 could be height adjustable relativeto the horizontal surface 24, such as on a sliding pin clamp or thelike, or one or more of the legs 29 (if present) could offer heightadjustability. If one or more legs 29 are used with accessory clamps Con the accessory mounting rail R, height adjustability could be providedby a selective insertion depth of the legs into the accessory clamps. Inyet another embodiment, the rigid support frame 22 can be of such afixed height above the operating room table mattress M that will avoidclashing with robotic arms when said rigid frame is being employedduring robotic assisted surgical interventions.

The vertical surface 26 has attached a quantity of an aggressivereleasable, repositionable fastener 28 that extends across all or aportion of a suitable support surface. The repositionable fastener 28allows adjustable, patient specific, placement of one or more paddedrestraints 30, and/or other supports or stabilizers, upon the rigidsupport frame 22. Preferably, the repositionable fastener 28 extendsacross a substantial or complete width of the vertical surface 26, asshown in FIG. 1, to allow substantially infinite adjustment of thepadded restraints 30 and/or other supports or stabilizers upon thesupport surface. Any or all off the padded restraints 30, supports orstabilizers may also have a corresponding compatible, aggressive,releasable and repositionable fastener system (described below) forcoupling to the rigid support frame 22. The repositionable fastener 28can be disposed partially or completely over the vertical surface 26 ofthe support frame 22 as one single continuous unit (see example of FIG.1), or two or more separate units (see example of FIG. 6). If separateunits are used, the repositionable fastener 28 can have the same ordifferent strengths or other properties. In one example, therepositionable fastener comprises a hook-and-loop type fastener. Inother examples, the repositionable fastener 28 includes snaps, hooks,clasps, clips, elastic members, tape, removable or non-permanentadhesives, etc. or combinations thereof. The repositionable fastener 28can be secured variously to the vertical surface 26, such by anon-removable adhesive or other snaps, hooks, clasps, clips, elasticmembers, tape, etc. Although the vertical surface 26 is described ashaving the repositionable fastener 28 thereon, it is contemplated thatthe horizontal surface 24 could feature a repositionable fastener 28 foruse with the padded restraint 30.

The second element of the arm restraint system 20 is a specially shaped,infinitely adjustable padded restraint 30 (see FIGS. 2-3) that wraps andis fastened around a portion of the patient's arm. The padded restraint30 or pad provides a soft flexible patient arm restraint device thatsafely restrains a patient's arms at their side during a surgicalintervention, and is compatible with all embodiments of the rigidsupport frames 22 discussed herein. The padded restraint 30 may befabricated from single or multi-use flexible padding material of suchthickness and density that may provide a safe environment for thepatient's upper extremity. The flexible padding material is fabricatedin a shape or configuration that, when wrapped around the patient's arm,exposes certain portions of the upper extremity located between theaxilla (i.e., armpit) and the tips of the patient's fingers. Theseexposed portions can be useful for the anesthesia team to provide easyand immediate access to IV lines (intravenous) and monitoring lines.

The padded restraint 30 is preferably formed as a monolithic bodyutilizing a single material, although it can be formed of multiplecomponents and/or multiple materials. The padded restraint 30 isintended only to stabilize the patient's arms against lateral and/ortorsional movement, and the combination of materials used should providestability for patients ranging from 45 lbs to greater than 450 lbs, andpreferably greater than 750 lbs. Additionally, the material can be anatural or synthetic material in such a size or density that willmaintain its shape and function and provide and maintain sufficientresistance to the patient's weight and gravity. The padded restraint 30includes a deformable material, such as foam, rubber, plastic, fabric orthe like, and more preferably the material is a resiliently deformablematerial. In one example, the padded restraint is made of polyether-typepolyurethane foam and has a density of at least 1 lbs per cubic foot,and more preferably at least 1.8 lbs per cubic foot. Additionally, thefoam material preferably has an indentation load deflection (ILD) ratingof at least 30 lbs., more preferably at least 40 lbs. An ILD rating is ahardness measurement of foam that is typically measured in the number ofpounds of pressure required to indent the foam by 25% using a 50 squareinch indentation (sometimes referred to as the 25% ILD rating). It isunderstood that the example load ratings described above are onlyexamples, and other values are contemplated. The use of a deformablematerial ensures no undue compression of the arm, which significantlyreduces the risk of posturing related injury including pressure points,stretched nerves and constrictions. Additionally, the padded restraintallows easy manipulation of the position of the limb, making it possibleto assure desired compression loading and orientation of the extremity.

As mentioned above, the padded restraint 30 can be a monolithic body, orcan include two or more components. In one example, the padded restraintcan be manufactured from a single piece of foam or other unitarymaterial. In another example, the padded restraint can beco-manufactured (e.g., such as using fasteners, adhesives, co-molding,co-extrusion, etc.) using two or more materials. Moreover, the paddedrestraint can be disposable, limited use or reusable. In a reusableconfiguration, the padded restraint can include an outer covering 31(shown schematically in FIG. 2) that is either replaceable (e.g., awashable or single-use covering) or the outer covering can benon-replaceable but suitable to be cleaned and sanitized per medicalstandards. Preferably, the outer covering 31 substantially completelycovers the entire padded restraint 30 on all sides. For example, thepadded restraint could have a plastic, gel or other medically-suitablematerial coated, laminated, etc. on its exterior. Preferably, the outercovering 31 is deformable to move together with the padded restraint.

In each embodiment, patient restraints, supports and stabilizers may beattached to and project from said frame 22 being attached to thevertical surface 26 of said frame 22 using corresponding aggressive,releasable fasteners 34 compatible with that utilized on the supportframe or sled. The releasable fasteners 34 permit infinite adjustmentand relocation of the padded restraint 30, and/or other supports orstabilizers, on the rigid support frame 22 that are being utilized tosupport or restrain the patient's arm at the side of the body. In oneexample, the repositionable fasteners 34 comprise a hook-and-loop typefastener. In other examples, the repositionable fastener 34 includessnaps, hooks, clasps, clips, elastic members, tape, removable ornon-permanent adhesives, etc. or combinations thereof. In any event, thefasteners 34 should be compatible with and correspond to the fasteners28 of the rigid support frame 22.

The padded restraint 30 is shaped to conform to and encompass thepatient extremity to be supported. In one example, the padded restraint30 as an arm support may be shaped in a form somewhat resembling theletter “H.” That is, as shown in FIGS. 2-3, the padded restraint 30 canhave a central body 36 with a first pair of projections 38 bounding afirst cutout 39, and an opposite second pair of projections 40 boundinga second cutout 41. The first and second cutouts at least partially lineup with each other, and preferably substantially line up with each other(possibly being a mirror image of each other) across a centerline of thecentral body 36. The first and second pair of projections 38, 40,together with the first and second cutouts 39, 41, can provide thepadded restraint 30 with a generally “H”-shaped geometry. The inside ofthe padded restraint is intended for patient contact and is smooth. Thedeformable material further enhances the even re-distribution ofpressure over the entire supported surface. In one example, the paddedrestraint is approximately 18.5″ wide×20″ tall×0.625″ thick, althoughother shapes and sizes are contemplated.

The padded restrain further includes one or more integrated tabs 32within the flexible padding material. The tabs 32 are located generallyon the central body 36, and each tab is preferably in line with one ofthe first pair 38 and the second pair 40 of projections. Preferably,each one of the first pair 38 and the second pair 40 of projections arearranged in a straight line and may comprise a mirror image of eachother along a center line of the padded restraint 30. Additionally, eachtab 32 is preferably centrally located generally between one of thefirst pair 38 and the second pair 40 of projections. Preferably, thetabs 32 are monolithic with the padded restraint, and comprise flexible,partial cut-out sections to create an integrated hinge and perimeterreinforcement. Each tab 32 may be formed using a “U”-shaped cutout ofthe central body 36 to provide living hinge along one edge of the tab 32so that the tab 32 is flexibly bendable relative to and independent ofthe central body 36. The integrated tabs 32 may fold outwards to permitthe central body 36 of the padded restraint 30 to move somewhat withrespect to the rigid support frame 22 while the tabs 32 are secured tothe rigid support frame 22. This construction accommodates minor patientarm movements.

A rear portion (i.e., non-patient contact side) of the tabs furtherincludes corresponding aggressive, releasable fasteners 34 compatiblewith the fasteners 28 utilized on the rigid support frame 22. Theflexibility of the tabs 32 facilitates the usage of the padded restraint30 to be wrapped and secured around the patient's arm. Morespecifically, the tabs 32 may be hinged in a manner that allows thepermanent or re-closable fasteners 34 thereon to be connected directlyto the mating fasteners 28 on the medial aspect of the vertical surface26 of the rigid support frame 22. The tabs 32 are hinged in a mannerthat, when fastened to the rigid support frame 22, allows the centralbody 36 of the padded restraint 30 to be opened to encompass or containthe upper extremity. The tabs 32 may be adjusted to the left or rightrelative to the horizontal surface 24 of the rigid support frame 22 inorder to provide desired or maximum coverage on the upper extremity.Still, it is contemplated that the fasteners could be permanentlyfastened to the rigid support frame 22.

Once attached to the rigid support frame 22, and adjusted to thepatient's upper extremity to maximize support and wrapped around theupper extremity, additional permanent or re-closable fasteners 42, 44are employed to secure the position of said padded restraint 30 upon andencompassing the patient's upper extremity. As shown in the top view ofFIG. 4, the additional fasteners 42, 44 may be secured to the paddedrestraint 30 in such a manner to allow a wrapping and closure about thepatient's upper extremity. For example, each of the first pair ofprojections 38 of the padded restraint 30 can have one part of there-closable fastener 42 secured thereto, while each of the second pairof projections 40 can have a corresponding second part of there-closable fastener 44 secured thereto. The first part of there-closable fastener 42 can be extend towards and/or be co-terminus withthe edge of the first pair of projections 38, while the second part ofthe re-closable fastener 44 can extend a distance beyond the edge of thesecond pair of projections 40. Then, once the padded restraint 30 iswrapped into a cylindrical shape about the patient's arm, the secondpart of the re-closable fastener 44 can be pulled over to fasten ontothe first part of the re-closable fastener 42 to secure the first andsecond pairs of projections 38, 40 together, as shown in FIG. 4.Preferably, the re-closable structure of the fasteners 42, 44 isfastenable along their length so that length of the closure isadjustable to thereby adjust the overall diameter of the cylindricalshape of the padded restraint 30 to be a custom fit upon the patient'sarm.

Turning to FIGS. 5-10, an example usage will be described. First thepadded restraint 30 is placed face down upon a table or other surface,with the fasteners 34 of the tabs 32 exposed upwards. The tabs 32 aregently pulled upwards to separate them from the central body 36 of thepadded restraint. Next, the padded restraint 30 is flipped over to beface up on the table or other surface. As shown in FIG. 5, the first andsecond pairs 38, 40 of projections are lifted upwards and generallytowards each other so that the padded restraint 30 forms a “U”-shape,with the central body 36 remaining upon the table or surface. Thisgeometry will separate the tabs 32 from the central body 36 and placethem in a position to be secured to the rigid support frame 22. Turningto FIG. 6, the repositionable fasteners 34 of the tabs 32 are secured tothe corresponding repositionable fasteners 28 on the medial aspect ofthe vertical surface 26 of the rigid support frame 22 and the paddedrestraint is held in place (horizontally and vertically). The user willlocate the padded restraint 30 at the desired position upon the rigidsupport frame 22, and will secure the tabs 32 to the frame 22. At thisstage, the padded restraint 30 is secured to and movable with the rigidsupport frame.

Next, as shown in FIG. 7, the rigid support frame 22 is placed in thedesired operative position on the surgical table T and is coupledthereto. In the shown example, the horizontal surface 24 of the rigidsupport frame 22 is slid underneath the patient mattress M of thesurgical table T to be held between the mattress M and the top surfaceof the surgical table T and held in place by friction and the weight ofthe lower torso of the patient. The familiar configuration will allowsurgical assistants unobstructed access to the side of the operatingroom table or examination table. The position of the rigid support frame22 and padded restraint 30, relative to the patient and surgical tableT, may be adjusted at this time. As shown in FIG. 8, the rigid supportframe 22 is pressed inwards towards the patient and surgical table Tuntil it is snugly fit against the side of the mattress M.Alternatively, if the rigid support frame 22 is to be secured to thesurgical table T via legs 29 or the like, these are secured at thistime. Even so, the rigid support frame 22 will still appear as shown inFIG. 8. At this time, the tabs 32 are clamped between the verticalsurface 26 of the rigid support frame 22 and the exterior side edge ofthe mattress M. The first and second pairs of projections 38, 40 form agenerally “L”-shape and are ready to receive the patient's arm.

To secure the patient's arm within the padded restraint 30, as shown inFIG. 9, both the head facing and foot facing extension sections of thelateral portion of the arm strip (i.e., the outer portions of the“H”-shape) are each wrapped around the patient's arm. That is, both ofthe first and second pairs of projections 38, 40 are wrapped upwards toform a cylindrical geometry (e.g., see FIG. 4) to snugly retain thepatient's arm. Preferably, portions of the first and second pairs ofprojections 38, 40 overlap each other. The medial section arm stripseach have the repositionable fasteners 42, 44 (e.g., illustrated ashook-and-loop straps or belts) that are brought over the arm andattached to the corresponding fasteners 42, 44 on the lateral first andsecond pairs of projections 38, 40 of the corresponding side. Finally,as shown in FIG. 10, one end of a belt is attached to the medial side ofthe pad and the belt passes over the extremity and the distal end of thebelt is attached to the opposite fastener. The belt is adjustable alongits length and may be opened or closed many times to ensure a snug fitof the padded restraint 30 about the patient's arm. The padded restraintmay also be adjusted on the rigid support frame 22 by repositioning therepositionable fastener tabs horizontally toward the patient's head orthe feet. Desired coverage of the limb may be accomplished by adjustingthe padded restraint to the desire position on the frame 22. This allowsprotection of fingers and nerves and serves to minimize compression.Additionally, the recloseable fasteners permit the anesthesia team easyand immediate access to IV lines and monitoring lines by partially orcompletely opening up the padded restraint. Additionally, when the firstand second pairs of projections 38, 40 are wrapped upwards to form acylindrical geometry, an at least partial alignment of first and secondcutouts 39, 41 provides an upward access opening 46 extending throughthe padded restraint to the patient's arm in the normal operationalposition (see FIG. 4). Even in the regular course of a surgicalprocedure, this upward access opening 46 provides medical personnel withfast and easy anesthesia access and exposure to the patient's arm, aswell as IV lines, monitoring lines and ports. As can be appreciated,greater alignment of the first and second cutouts 39, 41 can provide arelatively larger upward access opening 46. In addition oralternatively, different alignments of the first and second cutouts 39,41 and/or specific geometry of the first and second cutouts 39, 41 (oreven additional cutouts) could be used to provide specialized accessopenings for particular desired purposes and/or at particular locationsor orientations. Finally, once both of the repositionable fasteners 42,44 on the first and second pairs of projections 38, 40 are coupledtogether, the patient's arm is secured to the surgical table T. Theprocess is repeated for each arm.

It is typical that padded restraints may be advantageously employed inmedical procedures requiring the supine position including flat, lateraltilt or head down supine position (Trendelenburg) and is usedbilaterally to support both limbs. In some embodiments, a devicecombines the use of several restraint, support or stabilizing devicesembodied in the claims to restrain the patient's arm. For example, twopadded restraints mounted on sleds may be used to restrain and positiona patient's arms for those gynecological, cystoscopic and urologicallithotomy procedures.

Turning now to FIGS. 11-12, the arm restraint system, in addition oralternatively, can include a width extender to easily accommodate thearms of patients with a high body-mass index (BMI). For example, asecond example rigid support frame 50 can have an increased width in thehorizontal direction, and may also have an increased height in thevertical direction. In the shown example, the horizontal surface 52 caninclude an auxiliary horizontal surface 54 that can thereby increase thewidth of the rigid support frame 50. Preferably, the auxiliaryhorizontal surface 54 extends along the entire lateral edge of the rigidsupport frame 50, such as substantially coextensive with the verticalsurface 55 (although the auxiliary surface 54 can be wider or shorter).The main horizontal surface 52 (which extends underneath the tablemattress M) may have a relatively narrower profile to avoid contact withother parts of the surgical table T top. The vertical surface 55 canincorporate an aggressive releasable fastening system 58 of the typespreviously described herein (i.e., fastening system 28). A bariatricextender pad 56 or block may be used between the rigid support frame 50and the padded restraint 30 to properly position the patient's largerarm. In one example, the extended bariatric version can add 4 inches ofwidth and can keep the patient's arms at the same level as the table padto safely secure the arms of patients up to 750 lbs. That is, theauxiliary horizontal surface 54 can add the desired extra 4 inches toeffectively re-locate the vertical surface of the rigid support frame 50laterally outward of the surgical table T. The bariatric extender pad 56or block can have various shapes and sizes, such as 2″ tall×3″ wide×20″long, although other sizes are contemplated. Preferably, the bariatricextender pad 56 or block has an installed height generally similar tothe height of the surgical table T mattress M. Preferably, the bariatricextender pad 56 or block is made of the same or similar deformablematerial as the padded restraint. The bariatric extender pad 56 or blockcan be permanently or removably secured to either of the sled or paddedrestraint, such as held in place by friction due to the weight of thepatient's arm, or secured to the rigid support frame 50 byre-positionable fasteners similar to those described herein, or evensecured by permanent fasteners. In use, it is contemplated that thebariatric extender pad 56 or block is coupled to the rigid support frame50 after the padded restraint 30, but prior to securing the rigidsupport frame 50 to the surgical table T. The padded restraint 30 can besubstantially similar to that previously described herein, which may beattached to the second example rigid support frame 50 in substantiallythe same manner.

The invention creates an environment for patient safety that is capableof maintaining the arms of patients with normal and high body massindexes restrained in a familiar position at the side of the body whilemaintaining the arm at mattress M level. It eliminates the need for adraw sheet that when used to create a tucking restraint for the armcreates undue compression on nerves. The H shape of the pad (providingthe upward access opening 46) and the recloseable fasteners permit theanesthesia team easy and immediate access to IV and monitoring linesregardless of the inclination of the surgical table T and therecloseable fasteners permit a fast, safe and secure method to re-securethe arm. The low profile of the frame secures the patient restraint padto assure arm security, and the low profile does not clash with therobot arm. Moreover, the physical profile of the device is notbothersome to surgical assistants.

The invention successfully reduces the risk for operating room acquiredpatient arm injuries while providing a stable horizontal, vertical andlateral restraint platform for the upper extremities during thepatient's experience on the operating room table. I have discovered thatcreating a fully adjustable arm restraint that utilizes the ergonomicadvantages of a modified “toboggan” and the safety and stability of anarm restraint system that does not come from under the body can provideimproved access for anesthesia to the arm, eliminate clash betweenrobotic arms and the arm stabilizer, reduce anesthesia time and improvepatient outcomes. Some of the innovative elements of the inventioninclude, without limitation, the combination of a multiply adjustable Hshaped arm restraint with built in stabilizing tabs and the low profilearm coupler.

No other design has attempted to solve these issues in this manner.There are few inventors working on patient positioning products for theoperating room and the concept of creating a hybrid utilizing thefeatures of two dissimilar technologies has not been apparent to others.My unique clinical experience, design background, and intimacy in themarketplace are the reason that I am the only person who has createdsuch a device.

The following definitions are provided for terms used herein.

Supine: The patient lays on the table on their back.

Trendelenburg: The table is tilted in the head down position (typically1 degree to 60 degrees).

Toboggan: Arm restraint that encompasses the arm—named after appearance.

Sled: Arm restraint that holds the restraint pad that encompasses thearm—named after appearance.

Draw Sheet: woven or non-woven sheet placed transversely across theoperating room table. Typically used to assist in moving patients. Theexcess on each side is conventionally used to tuck patient arms.

Neuropathy: An injury to a nerve.

Easily re-closable fasteners: Common reference to hook and loopfasteners (one commercial example is VELCRO(R)).

Anesthesia monitoring lines: Electrically conductive lines attachingcertain parts of the body to monitoring systems.

Robot arm: An appendage of the surgical robot (such as the Da Vincirobot) that is capable of holding and operating certain surgicalinstruments.

AORN: An association of operating room nurses. Considered the governingbody with regards to certain guidelines including patient positioning.

IV Infiltration: Typical result of the displacement of the IV needlefrom the vein into adjoining tissues causing swelling or edema.

Compartment Syndrome: Damage of muscle that is encapsulated in fasciaresulting in internal pressures capable of disrupting blood flow to thestructure.

Ergonomic arm's length: Anthropomorphic images—showing surgeon stancewith arms lowered and 90 degrees to patient.

Surgical Drape: A sterile covering material that typically utilizes afenestration to isolate the surgical site from the patient. Typicaldrapes will cover an area approximately 50% larger than the patient.

Lateral: away from the midline.

Medial: toward the midline.

Egg crate foam: Typical a low density foam. Named based on theappearance of the foam configuration.

Surgical table T accessory rail: Most surgical table Ts have anaccessory rail on each side that runs parallel with the table top. Theyare typically segmented to allow free articulation of table sections.

BMI ratings: A formula utilizing patient size and weight has beenutilized to determine.

Body Mass Index: The higher the BMI the more obese the patient.

Perineal cutout: This feature on operating room tables permits optimalaccess to the patient's perineum.

Perineum: The area located between reproductive structures and the anus.

The invention has been described with reference to the exampleembodiments described above. Modifications and alterations will occur toothers upon a reading and understanding of this specification. Examplesembodiments incorporating one or more aspects of the invention areintended to include all such modifications and alterations insofar asthey come within the scope of the appended claims.

What is claimed is:
 1. A padded restraint for restraining movement of anarm of a patient's body lying over a top surface of a table, the paddedrestraint comprising: a central body configured to be disposed over oradjacent a top surface of a mattress lying over a top surface of saidtable and configured to be removed from disposition between the mattressand the table, the central body configured for use with an armpositioned laterally adjacent the patient's body; a first pair ofprojections extending outwards from the central body and comprising afirst cutout portion therebetween; a second pair of projectionsextending outwards from the central body in a direction opposite thefirst pair of projections and comprising a second cutout portiontherebetween; and a pair of cutouts formed in the central body andsurrounded by a surface of the central body to define a pair of tabs,each tab having a living hinge along one edge of the tab, the pair oftabs being independently movable relative to each other between a firstposition wherein the tabs are received in an opening bounded by thecutouts and a second position wherein the tabs protrude from the surfaceof the central body, each tab further comprises a repositionablefastener on an exterior surface thereof, wherein the tabs are locatedupon the central body between the first pair of projections and thesecond pair of projections, wherein all of the central body, first pairof projections, second pair of projections, and pair of tabs comprise aunitary body made of one or more deformable materials.
 2. The paddedrestraint of claim 1, wherein the first pair of projections comprises arepositionable fastener thereon that extends towards and/or isco-terminus with an edge of the first pair of projections, and thesecond pair of projections comprises a compatible repositionablefastener upon a strap that extends a distance beyond an edge of thesecond pair of projections.
 3. The padded restraint of claim 1, whereinthe padded restraint is sufficiently flexible to be wrapped about thepatient's arm, with the first and second pairs of projections in anoverlying arrangement, and secured onto the patient's arm via engagementof the repositionable fasteners of the first and second pairs ofprojections.
 4. The padded restraint of claim 1, wherein the firstcutout portion is substantially in alignment with the second cutoutportion across the central body so that, when the padded restraint iswrapped onto said patient' arm, the first cutout portion and the secondcutout portion substantially align to form an upward access openingextending through the padded restraint to said patient's arm.
 5. Thepadded restraint of claim 1, wherein each cutout has a “U”-shapedgeometry and is centrally located between one of the first pair and thesecond pair of projections.
 6. The padded restraint of claim 1, whereinthe padded restraint has a “H”-shaped geometry formed by the first andsecond pair of projections together with the first and second cutouts.7. The padded restraint of claim 1, wherein substantially all of a rearnon-patient contact side of each tab comprises the repositionablefastener.
 8. The padded restraint of claim 1, wherein all of the centralbody, first pair of projections, second pair of projections, and pair oftabs comprise a monolithic body made of a single deformable material andwherein said single deformable material is made of a polyether-typepolyurethane foam and has a density of at least 1 lbs per cubic foot. 9.The padded restraint of claim 1, wherein the first pair of projectionsand the second pair of projections are configured to couple to oneanother and to form a tubular geometry that is pivotable relative to thepair of tabs fastened to a surface.
 10. A padded restraint forrestraining movement of an arm of a patient's body lying over a topsurface of a table, the padded restraint comprising: a central bodyconfigured to be disposed over or adjacent a top surface of a mattresson the table and removed from disposition between the mattress and thetable, and configured to at least partially receive the arm of saidpatient and including a deformable material, a pair of cutouts formed inthe central body and surrounded by a surface of the central body, eachcutout defining at least two sides of a corresponding tab that ismonolithic with the central body, each tab having an additional sideconnected to the central body to define a living hinge of the tab, eachof the tabs being independently movable relative to each other and thecentral body between a first position wherein the tabs are received inan opening bounded by the cutouts and a second position wherein the tabsprotrude from the surface of the central body, the tabs each furthercomprising a first repositionable fastener, a first pair of projectionsmonolithic with the central body, the first pair of projectionsextending outwards from the central body and comprising a secondrepositionable fastener thereon, and a second pair of projections alsomonolithic with the central body, the second pair of projections locatedopposite the pair of first projections and extending outwards from thecentral body and comprising a third repositionable fastener thereon thatis compatible with and fastenable with the second repositionablefastener, wherein the central body is configured to be wrapped in atubular geometry about the patient's arm, with the first pair ofprojections and the second pair of projections in an overlyingarrangement and secured upon the patient's arm via engagement of thesecond and third repositionable fasteners.
 11. The padded restraint ofclaim 10, wherein the central body is configured to be securely fixed toa surface extending outwardly from a plane of a top surface of the tableupon which said patient's body is lying via engagement of the firstrepositionable fastener of the pair of tabs with a compatible fastenerat the surface, to thereby inhibit movement of the patient's armrelative to the surface and to thereby maintain the arm at a positionlaterally adjacent to said patient's body absent the arm beingrestrained by tucking.
 12. The padded restraint of claim 10, wherein thecentral body is made of a polyether-type polyurethane foam and has adensity of at least 1 lbs per cubic foot.
 13. The padded restraint ofclaim 10, wherein the first repositionable fasteners comprisehook-and-loop type fasteners.
 14. The padded restraint of claim 10,wherein the tabs comprising the first repositionable fasteners arespaced apart along a longitudinal length of the central body, providinga gap therebetween for allowing access to the patient's arm at the gap.15. The padded restraint of claim 10, wherein one of the pairs of secondrepositionable fasteners and third repositionable fasteners extendrespectively from the pair of first repositionable fasteners, andwherein the other of the pairs of second repositionable fasteners andthird repositionable fasteners are spaced from the pair of firstrepositionable fasteners.
 16. The padded restraint of claim 10, whereinthe second and third repositionable fasteners are hook-and-loop typefasteners, and one of the second or third repositionable fasteners isprovided upon a strap that extends a distance beyond an edge of thepadded restraint.
 17. The padded restraint of claim 10, wherein each tabis centrally located generally between the first pair of projections andthe second pair of projections.
 18. The padded restraint of claim 10,wherein the cutouts are “U”-shaped and the living hinge of thecorresponding tab is disposed between legs of the “U”-shaped cutout. 19.The padded restraint of claim 10, wherein substantially all of a rearnon-patient contact side of each tab comprises the first repositionablefastener.
 20. The padded restraint of claim 10, wherein the tubulargeometry is pivotable relative to the pair of tabs when the tabs arefastened to a surface relative to the table for supporting the patient.